[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cold-agglutinin-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cold-agglutinin-disease":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":5},"100510844","prospective-evaluation-of-diagnosis-and-treatment-of-patients-with-autoimmune-cytopenias-including-autoimmune-hemolytic-anemia-immune-thrombocytopenia-and-chronic-idiopathicautoimmune-neutropenia-100510844",false,"NCT05931718","Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic\u002FAutoimmune Neutropenia","Evaluation of the Diagnostic\u002FTherapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic\u002FAutoimmune Neutropenia CIN\u002FAIN) and Identification of Predictive and Prognostic Markers.","AIHA ITP CIN","Inclusion Criteria:\n\n* Diagnosis of autoimmune cytopenias (AIHA\u002FITP\u002FCIN\u002FAIN)\n* age \\>\u002F= 18 years\n* ability to sign informed consent\n* availability to undergo 3 year follow up\n* for the subgroup of patients with myelodysplastic syndrome: bone marrow evaluation showing \\>\u002F= 10% dysplastic features of at least one lineage along with MDS defining cytopenia and\u002For MDS defining cytogenetics.\n\nExclusion Criteria:\n\n* any condition impeding the acquisition of the informed consent\n* immune cytopenia diagnosis preceding \\>\u002F= 6 months the enrolment","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic\u002Fautoimmune neutropenia.\n\nThe main aims to answer are:\n\n* evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome.\n* evaluation of type and sequence of the therapies administered, the response rates, and the adverse events.\n* evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome.\n* evolution of autoimmune cytopenias into myelodysplastic syndromes.\n* a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism.\n\nParticipants will receive a clinical\u002Flaboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.",[25,26,27,28,29,30],"Autoimmune Hemolytic Anemia","Immune Thrombocytopenia","Chronic Idiopathic Neutropenia","Autoimmune Neutropenia","Myelodysplastic Syndromes","Cold Agglutinin Disease",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"autoimmune hemolytic anemia","immune thrombocytopenia","chronic idiopathic neutropenia","autoimmune neutropenia","cold agglutinin disease","myelodysplastic syndromes","rituximab","thrombopoietin receptor agonists","erythropoietin","steroids","splenectomy","red cell metabolism","cytokines","luspatercept","microbiome","single cell analysis","next generation sequencing","RECRUITING","2024-10-08",{"date":52,"type":53},"2024-10-15","ACTUAL",{"date":55,"type":53},"2019-06-01",{"date":57,"type":21},"2035-06",{"name":59,"class":60},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER"]